The Effect of Two Dietary Interventions on the Symptomatic Control of People Living With Anxiety Disorders.

Anxiety Disorders Clinical Trial

Official title:

The Effect of Two Dietary Interventions on the Symptomatic Control of People Living With Anxiety Disorders.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04586829
• Other study ID #: UIE-3506-20-21-1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2022
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomised controlled trial will evaluate the effect of a ketogenic diet vs a conventional diet on the symptoms of patients living with anxiety disorders using a validate self-reported inventory.

Description:

It has been theorized that ketogenic diet could improve symptom control in patients living with anxiety disorders. Animal models support this hypothesis but to this date, studies in humans are lacking.

The investigators will randomise patients with a confirmed diagnosis of anxiety disorders to follow a ketogenic diet (<50 grs of carbohydrate per day) or a conventional diet (50% carbohydrate, 30% lipids, 20% protein) for one month.

Symptom control will be assessed weekly using Beck's inventory for Anxiety. Diet adherence will be measured using standardised food frequency logs and acetoacetate urine strips.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 35
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a confirmed diagnosis of Anxiety Disorder by Psychiatrist.

Exclusion Criteria:

• Patients with the diagnosis of drug abuse, cognitive impairment or dementia, porphyria, carnitine translocase deficiency and carnitine palmitoyl transferase deficiency.

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Other:
• Diet
<50 grams of total carbohydrates per day. Monosaturated fats consumption will be encouraged over saturated fats.

Locations

Country	Name	City	State
Mexico	INCMNSZ	Mexico City	Cdmx

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

Ari C, Kovács Z, Juhasz G, Murdun C, Goldhagen CR, Koutnik AP, Poff AM, Kesl SL, D'Agostino DP. Corrigendum: Exogenous Ketone Supplements Reduce Anxiety-Related Behavior in Sprague-Dawley and Wistar Albino Glaxo/Rijswijk Rats. Front Mol Neurosci. 2017 Feb 13;10:36. doi: 10.3389/fnmol.2017.00036. eCollection 2017. — View Citation

Fydrich, T., Dowdall, D. and Chambless, D. L. (1992) 'Reliability and validity of the beck anxiety inventory', Journal of Anxiety Disorders, 6(1), pp. 55-61. doi: 10.1016/0887-6185(92)90026-4.

Kashiwaya Y, Bergman C, Lee JH, Wan R, King MT, Mughal MR, Okun E, Clarke K, Mattson MP, Veech RL. A ketone ester diet exhibits anxiolytic and cognition-sparing properties, and lessens amyloid and tau pathologies in a mouse model of Alzheimer's disease. Neurobiol Aging. 2013 Jun;34(6):1530-9. doi: 10.1016/j.neurobiolaging.2012.11.023. Epub 2012 Dec 29. — View Citation

Kovács Z, D'Agostino DP, Diamond D, Kindy MS, Rogers C, Ari C. Therapeutic Potential of Exogenous Ketone Supplement Induced Ketosis in the Treatment of Psychiatric Disorders: Review of Current Literature. Front Psychiatry. 2019 May 23;10:363. doi: 10.3389/fpsyt.2019.00363. eCollection 2019. Review. — View Citation

Saslow LR, Daubenmier JJ, Moskowitz JT, Kim S, Murphy EJ, Phinney SD, Ploutz-Snyder R, Goldman V, Cox RM, Mason AE, Moran P, Hecht FM. Twelve-month outcomes of a randomized trial of a moderate-carbohydrate versus very low-carbohydrate diet in overweight adults with type 2 diabetes mellitus or prediabetes. Nutr Diabetes. 2017 Dec 21;7(12):304. doi: 10.1038/s41387-017-0006-9. — View Citation

Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom control	Total points in Beck's Inventory for Anxiety. Scores range between 0 to 63 and higher numbers mean a worse outcome.	One month
Secondary	Subjective self perceived control	Self-assessed and reported symptom ranging between 0 - 100. Higher numbers mean a better outcome.	One month